Nanocrystalline Gold Treatment Improves Survival in Amyotrophic Lateral Sclerosis
In interim analysis of the open-label extension of the phase 2 RESCUE-ALS trial, nanocrystalline gold (CNM-Au8; Clene Inc, Salt Lake City, UT) significantly improved long-term survival of people with amyotrophic lateral sclerosis (ALS).
People treated with nanocrystalline gold vs placebo in the 36-week double-blind portion of the trial had an approximately 70% decreased risk of all-cause mortality (HR = 0.29, P=0.01) at week 137. Sensitivity analyses showed a significant survival benefit with nanocrystalline gold compared with predicted median survival (HR = 0.36, P=0.003).
“These clinical and survival data from RESCUE-ALS contribute to the growing body of evidence supporting the potential for CNM-Au8 as a disease-modifying therapy for ALS,” said Robert Glanzman, MD, FAAN, Clene’s chief medical officer.
Rob Etherington, Clene’s chief executive officer, added, “The impressive ALS survival benefits seen with CNM-Au8 treatment corroborate our thesis – energetic support of neurons may protect CNS health and slow neurodegenerative disease progression. We look forward to upcoming results from the HEALEY ALS Platform Trial and advancing CNM-Au8 development in ALS and other neurodegenerative diseases, including multiple sclerosis and Parkinson disease.”
Nanocrystalline gold treatment was well-tolerated with no significant safety findings reported during the open-label extension.